BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNNEX INC.

    MDR report key: 1210874 · Received October 22, 2008

    Report

    Report Number
    MW5008730
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    SUNNEX INC.
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    REFERENCE: MFR: SUNNEX INC., TYPE: HS. MODEL: WH-601E2N PART# 18394 CLASS 2, INPUT 120VAC 60HZ 0.5A, OUTPUT 12 VAC 60W. OPERATOR PLUGS IN FLEXIBLE GOOSENECK-STAND LAMP POWER CORD INTO A 120VAC POWER OUTLET RECEPTACLE. THERE IS A LOUD SPARK AND THE BREAKER BLOWS IN THE OPERATING ROOM. THIS SAME INCIDENT RECURRS USING A SECOND IDENTICAL LAMP, IN A DIFFERENT OPERATING ROOM, AT A LATER TIME. ANALYSIS OF INTERNALS OF THE LAMP PLUG SHOWS THAT LAMPS THAT DO NOT CAUSE THIS PROBLEM HAVE A SMALL RED CARDBOARD INSULATOR INSIDE THE PLUG HOUSING. THE TWO LAMPS WHICH CAUSED THE SHORT CIRCUIT DID NOT HAVE THE SMALL RED CARDBOARD INSULATOR IN PLACE. APPARENTLY THIS COMPONENT WAS OVERLOOKED AND NOT PLACED INSIDE CORRECTLY IN THE MANUFACTURING PROCESS FOR THE TWO DEFECTIVE LAMPS. ALL OUR LAMPS OF THIS MODEL HAVE QC STICKERS MARKED: 200602 - OK BY #02. WE HAVE REPORTED THESE INCIDENTS TO SUNNEX. NO PATIENTS OR EMPLOYEES WERE HURT. DATES OF USE: PURCHASED IN AUGUST 08. DIAGNOSIS OR REASON FOR USE: ILLUMINATE WORK SPACE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNNEX INC. MODEL WH-601E2N GOOSE-NECK LAMP (12VAC) KZF SUNNEX INC. WH-601E2N 200602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other